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Study of Epratuzumab in Systemic Lupus Erythematosus

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382837
First Posted: October 2, 2006
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  Purpose
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.

Secondary Outcome Measures:
  • To continue to assess the efficacy and tolerability of epratuzumab;
  • To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
  • To continue to assess epratuzumab on Health-related quality of life in lupus patients;
  • To continue to assess disease status as reported by the patient and physician.

Enrollment: 0
Study Start Date: January 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

  • Development of toxicity to Epratuzumab
  • Significant protocol deviations from SL0003 Study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382837


  Show 54 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Anna Barry UCB Pharma
  More Information

ClinicalTrials.gov Identifier: NCT00382837     History of Changes
Other Study ID Numbers: SL0005
EudraCT# 2006-003865-15
First Submitted: September 29, 2006
First Posted: October 2, 2006
Last Update Posted: May 21, 2014
Last Verified: March 2007

Keywords provided by UCB Pharma:
Lupus,
Antibody,
B-Cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases